Glossary

A defined quantity of starting material, packaging material or product processed in one process or series of processes so that it could be expected to be homogeneous.

Large-scale cell culture in which cell inoculum is cultured to a maximum density in a fermentor, harvested, and processed as a batch.

The process in which a fixed volume of sterile medium in a vessel is inoculated with a desired organism. The broth is fermented for a defined period to completion, without further additions of media. After discharging the batch, the fermenter is cleaned and rebatched with medium for another cycle. Two other types of fermentation cycles are fed batch and continuous

A distinctive combination of numbers and/or letters which specifically identify a batch.

(Synonyms: Lot Number, Code number, requisition number, packaging job number, or equivalent)

Synonyms: Lot Number, Code number, requisition number, packaging job number, or equivalent

(ICH Q7) A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and from which the production and distribution history can be determined.

(ASTM/PAT) A combination of numbers, letters, and/or symbols that uniquely identify a batch and from which the production and distribution history can be determined.

Execution of programs serially with no interactive processing.

The set of records of all relevant process information in any Physical or electronic format.

The use of validated in-process sampling and testing methods such that results prove the process has done what it purports to do for the specific batch concerned, assuming control parameters have been appropriately maintained.

Bureau of Alcohol, Tobacco and Firearms (United States Department of Justice)

The signaling rate of a line. It's the switching speed, or number of transitions [voltage or frequency change] made per second. At low speeds bauds are equal to bits per seconds; e.g., 300 baud is equal to 300 bps. However, one baud can be made to represent more than one bit per second.

Bureau of Biologics and Radiopharmaceuticals (Canada)

Blue Cross and Blue Shield Association Health Insurance

Blood Center of America

Branched-Chain Amino Acids

Bioanalytical Chemistry Branch (CFSAN)

Beneficial Clinical Event

Business Continuity Management

Business Continuity Plan

Bureau of Consumer Protection (FTC)

Breast Cancer Prevention Test

Biopharmaceutical Classification System

Bovine Calf Serum